BLES Biochemicals is a pharmaceutical and medical device manufacturer and distributor. It is a privately-owned, proudly Canadian company. Its pharmaceutical product, BLES®, is the market leader in Canada and several other countries. BLES® is life-saving medicine for premature infants and has treated over 160,000 patients to date. Its history has local roots; BLES® was discovered at Western University and continues to be manufactured in London, Ontario. In 2015, BLES® was rated as one of the top five discoveries at an Ontario university, alongside insulin.

The team at BLES Biochemicals continues to work hard to manufacture exceptional products; the welfare and happiness of patients and their families is our number one priority. Our goal is to continue making a positive impact on patients by producing high-quality products, expanding our global reach, and searching for ways to innovate.

• Prepare and update packaging and labelling documents for domestic and international markets.
• Correspond with suppliers and international regulatory teams in requisite timeframe.
• Work diligently with the packaging team at BLES Biochemicals Inc. to ensure that packaging processes are streamlined.

• Receive, evaluate and submit adverse reaction reports and medical device incidence reports to Health Canada and international regulatory teams, as required.
• Assist in preparation of the Periodic Benefit-Risk Evaluation Report (PBRER) on an annual basis.
• Assist with the review and maintenance of the Risk Management Plan.
• Monitor, assess, and annotate scientific literature on a routine basis.
• Assist in product recalls by preparing and tracking documentation under the supervision of senior staff.

• Maintain regulatory electronic files at BLES Biochemicals.
• Review, analyze and interpret relevant new regulations, guidelines, and policy documents.

• Post-graduate Certification in Regulatory Affairs 
• University degree in Life Sciences

• Ability to interpret and apply the Canadian Food and Drug Regulations, the Medical Device Regulations and relevant guidance documents, as well as international guidelines by ICH, EC, and others